A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study will evaluate the efficacy and safety of ALKS 5461.

Key facts

Study ID

NCT02158533

Run by

Alkermes, Inc.

People needed

385

Starts

2014-05-01

Expected to finish

2015-12-01

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
• Agree to use an acceptable method of contraception for the duration of the study
• Have a Major Depressive Disorder (MDD) primary diagnosis
• Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
• Additional criteria may apply

You may not qualify if…

• Have a current primary Axis-I disorder other than MDD
• Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
• Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
• Have attempted suicide within the past 2 years
• Have a positive test for drugs of abuse
• Are pregnant, planning to become pregnant, or breastfeeding
• Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
• Have had a significant blood loss or blood donation within 60 days
• Additional criteria may apply

Where it is running

• Alkermes Investigational Site — Birmingham, Alabama, United States
• Alkermes Investigational Site — Tucson, Arizona, United States
• Alkermes Investigational Site — Carson, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Sherman Oaks, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Upland, California, United States
• Alkermes Investigational Site — Hartford, Connecticut, United States
• Alkermes Investigational Site — Norwich, Connecticut, United States
• Alkermes Investigational Site — Coral Springs, Florida, United States
• Alkermes Investigational Site — Gainesville, Florida, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — Orlando, Florida, United States
• Alkermes, Investigational Site — Alpharetta, Georgia, United States
• Alkermes Investigational Site — Decatur, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Joliet, Illinois, United States
• Alkermes Investigational Site — Skokie, Illinois, United States
• Alkermes Investigational Site — Newburgh, Indiana, United States
• Alkermes Investigational Site — Valparaiso, Indiana, United States
• Alkermes Investigational Site — Owensboro, Kentucky, United States
• Alkermes Investigational Site — Baltimore, Maryland, United States
• Alkermes Investigational Site — Baltimore, Maryland, United States
• Alkermes Investigational Site — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.